Study Indicates a 100% Success Rate for Renal Denervation System

Published date : 08 October 2012
Article date : 08 October 2012


According to a press release from Medtronic, a feasibility study for the medical device manufacturer's next generation investigational multi-electroderenal denervation system has shown a 100% success rate in patients with treatment-resistant hypertension. 

They say that Medtronic successfully completed the first phase of the feasibility study of the device which features a simultaneously firing multi-electrode catheter and advanced radio-frequency generator. 9 patients were treated with a 100% acute success rate in accessing the vessels and delivering therapy.

The investigational next-generation Symplicity system is not commercially available anywhere in the world. According to Medtronic, the single-electrode Symplicity renal denervation system has been used for 5 years to treat more than 5,000 patients with treatment-resistant hypertension worldwide. The single-electrode Symplicity system’s catheter and proprietary generator and algorithms were developed through years of clinical experience to enhance the safety and effectiveness of the renal denervation procedure. The device is only available in the United States for investigational use.

Medtronic continues that the next-generation system will feature a new 4 electrode catheter that delivers RF energy simultaneously and is designed to significantly reduce ablation time during renal denervation procedures. The new catheter will be 6 Fr compatible, highly conformable and have a non-occluding design for ease of deliverability and consistency of RF energy application, while also enabling the treatment of a wide range of renal anatomies.

Apparently, the device incorporates a new generator with an improved user interface. The new generator will leverage the benefits of Medtronic’s proven and proprietary Symplicit treatment algorithm and will be compatible with both the single-electrode Symplicity catheter and the next-generation multi-electrode catheter.

Source: Medtronic Press Release, 03 October 2012

Read a report in Reuters here.

WhichMedicalDevice hosts details on Medtronic's Simplicity Catheter System (the device was manufactured by Ardian until January 2011, when the company was taken over by Medtronic) which delivers radiofrequency (RF) energy from within the renal artery to block conduction in the surrounding renal nerves. It thereby counteracts chronic activation of the sympathetic nervous system. According to the manufacturer, in addition to blood pressure reduction, this treatment has shown promising results for chronic kidney disease, insulin resistance and heart failure. Apparently, treatment is performed in the catheterisation laboratory using interventional techniques similar to those used in other endovascular procedures and does not involve a permanent implant.

An excellent overview of renal sympathetic denervation can be found in an editorial article added to our web site, earlier this year: Renal Sympathetic Denervation: rationale, evidence and future implications

The site also hosts 2 videos of great interest: the first, which can be accessed beneath the device description, is a short video by Ardian/Medtronic explaining the mechanism of treatment; and the second is a video of a live procedure using the device.



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